Havrix

DRUG DESCRIPTION

HAVRIX (Hepatitis A Vaccine) is a sterile suspension of
inactivated virus for intramuscular administration. The virus (strain HM175) is
propagated in MRC-5 human diploid cells. After removal of the cell culture
medium, the cells are lysed to form a suspension. This suspension is purified
through ultrafiltration and gel permeation chromatography procedures. Treatment
of this lysate with formalin ensures viral inactivation. Viral antigen activity
is referenced to a standard using an enzyme linked immunosorbent assay (ELISA),
and is therefore expressed in terms of ELISA Units (EL.U.).

HAVRIX contains the following excipients: Amino acid
supplement (0.3% w/v) in a phosphate-buffered saline solution and polysorbate
20 (0.05 mg/mL). From the manufacturing process, HAVRIX also contains residual
MRC-5 cellular proteins (not more than 5 mcg/mL), formalin (not more than 0.1
mg/mL), and neomycin sulfate (not more than 40 ng/mL), an aminoglycoside
antibiotic included in the cell growth media.

HAVRIX is formulated without preservatives.

HAVRIX is available in vials and prefilled syringes. The
tip caps of the prefilled syringes may contain natural rubber latex; the
plungers are not made with natural rubber latex. The vial stoppers are not made
with natural rubber latex.

What are the possible side effects of hepatitis A vaccine (Havrix, Vaqta)?

You should not receive a booster vaccine if you have ever had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with hepatitis A is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

What are the precautions when taking hepatitis a vaccine, inactivated (Havrix)?

Before getting hepatitis A vaccine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as neomycin, formalin, latex in some vials/prefilled syringes), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

If you have decreased immune function from other medications (see also Drug Interactions) or other illness (such as HIV, leukemia, lymphoma, other cancer), your body may not make enough antibodies to protect you from hepatitis A...